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NCT01898494 · ClinicalTrials.gov registry record · Phase 2
Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer
A Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 519
- Enrollment target
- 20
- Study locations
NCT01898494: Active Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, sponsored by ECOG-ACRIN Cancer Research Group.
NCT01898494 is a Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 519 participants, below the 1,255-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898494, a Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 519 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.
Primary Outcome
Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG carboplatin
- RADIATION intensity-modulated radiation therapy
- PROCEDURE Transoral surgery
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente Oakland-Broadway - Oakland
- Stanford Cancer Institute - Palo Alto
- UCSF Medical Center-Mount Zion - San Francisco
Colorado
- Rocky Mountain Cancer Centers-Boulder - Boulder
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- Porter Adventist Hospital - Denver
Florida
- University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Florida Hospital Orlando - Orlando
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University/Winship Cancer Institute - Atlanta
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Mayo Clinic in Arizona - Scottsdale
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2014-01-22 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT01898494 still lists
NCT01898494 is an interventional study that assigns participants to a tested intervention. The registered 519 participants enrollment target is mid-sized for trials with a published cap, below the 1,255-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (59% lower).
The record links to 4 conditions, with Human Papillomavirus Infection appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.
NCT01898494 names 20 study sites across 10 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01898494 about?
NCT01898494 is a clinical study titled "Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer". This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used...
What is the current status of trial NCT01898494?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 519 participants. The study started on 2014-01-22. Estimated completion is 2026-12.
What conditions does trial NCT01898494 study?
This clinical trial studies the following conditions: Human Papillomavirus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Oropharynx.
What interventions are being tested in trial NCT01898494?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), intensity-modulated radiation therapy (RADIATION), Transoral surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01898494?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01898494 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01898494's enrollment target sits among peer trials
519 9th of 22 higher than 14 of 22 other Human Papillomavirus Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papillomavirus Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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